BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX? TRACHEOBRONCHIAL

    MDR report key: 3041486 · Received April 8, 2013

    Report

    Report Number
    3005099803-2013-02419
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ONLY THE DEPLOYED STENT WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED STENT FOUND THAT A STENT ROW FROM ONE END OF THE STENT HAD UNRAVELLED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED, WHICH CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE INVESTIGATION CONCLUDED THAT THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A BRONCHIAL STENT PLACEMENT PROCEDURE ON (B)(6), 2013.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER PLACING THE STENT, THE DOCTOR WANTED TO ADJUST THE POSITION OF THE STENT AND PULL IT PROXIMAL. THE DOCTOR GRABBED THE GREEN SUTURE AND THE TOP PART OF THE STENT WITH A BIOPSY FORCEPS, AFTER USING EXCESSIVE FORCE THE TOP ROW OF THE STENT WIRES UNRAVELLED FROM THE BODY OF THE STENT AND THE SUTURE BROKE. THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED TO COMPLETE THE PROCEDURE.THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A BRONCHIAL STENT PLACEMENT PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER PLACING THE STENT, THE DOCTOR WANTED TO ADJUST THE POSITION OF THE STENT AND PULL IT PROXIMAL. THE DOCTOR GRABBED THE GREEN SUTURE AND THE TOP PART OF THE STENT WITH A BIOPSY FORCEPS, AFTER USING EXCESSIVE FORCE THE TOP ROW OF THE STENT WIRES UNRAVELLED FROM THE BODY OF THE STENT AND THE SUTURE BROKE. THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143666 ULTRAFLEX? TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00564780 0015576352

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention